Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Motor evoked potential (MEP), before cross-over
研究概览
简要总结
This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-70
- •Scheduled for elective spine surgery requiring monitoring of evoked potential
- •ASA physical status 1-3
排除标准
- •Uncontrolled DM (HbA1c ≥ 9%)
- •Contraindications to the study drug: known allergy or hypersensitivity
- •Use of rate responsive cardiac pacemaker with bioelectrical impedence
- •Diagnosed neuromuscular disorder
- •Pre-existing motor weakness
研究组 & 干预措施
Propofol-Remimazolam
General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.
干预措施: Propofol (Drug)
Propofol-Remimazolam
General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.
干预措施: Remimazolam Besylate (Drug)
Remimazolam-Propofol
General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.
干预措施: Propofol (Drug)
Remimazolam-Propofol
General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.
干预措施: Remimazolam Besylate (Drug)
结局指标
主要结局
Motor evoked potential (MEP), before cross-over
时间窗: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes
Amplitude and latency of MEP before cross-over
MEP, after cross-over
时间窗: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes
Amplitude and latency of MEP after cross-over
次要结局
- Bispectral index(Intraoperative)
- Heart rate(Intraoperative)
- Blood pressure(Intraoperative)
研究者
Seok Kyeong Oh
Assistant Professor
Korea University Guro Hospital